Montreal, Canada, January 23, 2020 – Immuno-oncology company EpicentRx has seen improved efficiency and productivity since using Montrium’s electronic trial master file software, eTMF Connect. To meet patients’ critical unmet needs and provide innovative drug solutions, the EpicentRx team was looking for alternative ways to be more efficient with their trial master file (TMF) management. Now working with Montrium’s eTMF Connect for over one year, EpicentRx has seen heightened efficiency and productivity with the increased organization of data and records, the use of TMF data reporting features, and enhanced collaboration amongst sites and study teams.
Previously, the EpicentRx team utilized a paper-based TMF which challenged the existing team, making collaboration and review difficult, thus preventing scalability. As stated by Gina Varner, Director of Regulatory Affairs at EpicentRx, “Managing and filing in the paper TMF was too slow-moving, and it was also difficult to have a real-time assessment of completeness of TMF.”
The EpicentRx team was looking for a different way to increase productivity and efficiency within a central application. Montrium stood out in EpicentRx’s vendor evaluation as eTMF Connect was cost-effective and provided a user-friendly interface with powerful TMF capabilities.
Varner shares, “When initially uploading documents and comparing them to the system’s placeholders aligned with the DIA’s TMF Reference Model, right away we could see in the eTMF Connect Navigator what was effectively complete, any documents we were missing, and any titles that needed to be named differently.”
The transition to Montrium’s eTMF Connect improved collaboration and accurate reporting, allowing for increased efficiency while remaining compliant with the requirements of 21 CFR Part 11.
Daniel Cadoch, Customer Success Manager at Montrium shares, “After the implementation of eTMF Connect, we focused on making sure that the EpicentRx team was seeing results when it came to efficient use and management of the TMF, so they can take on new projects without adding significant time and costs. We are delighted to continue this partnership with the EpicentRx team and help them drive further success in their biotechnology research.”
To learn more about EpicentRx’s TMF transformation, read the full Success Story.
Founded in 2005, Montrium is one of the leading providers of cloud-based collaborative content management software to the life sciences industry. With experience in serving over 200 life science customers in 20+ countries, Montrium is committed to delivering an unparalleled customer experience to emerging growth organizations as a true technology partner. Montrium is headquartered in Montreal, Canada, with a European office in Brussels, Belgium.
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EpicentRx is a patient-driven immuno-oncology company with headquarters in La Jolla, California. The company’s new mechanisms of immunotherapy work across diverse patient populations and tumor types with minimal toxicity, enabling the best-possible quality of life during treatment. EpicentRx’s lead program, RRx-001, has been tested in several clinical trials including an ongoing Phase 3 study in small cell lung cancer. In addition, the company is advancing multiple programs through its smart virus platform.
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